Health product recall

Medfusion 3500 Syringe Infusion Pumps

Last updated

Summary

Product
Medfusion 3500 Syringe Infusion Pumps
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Medfusion Syringe Infusion Pumps Contact the manufacturer 3500VX-500 3500VX-415 3500 3500-415 3500-306 3500-414 3500-500 3500SD 3500VX 3500BC 3500VX-306
Pharmguard Toolbox Version 1.5 Contact the manufacturer 22-3510-51

Issue

Smiths Medical identified legacy software anomalies which may occur in the Medfusion 3500 syringe infusion pumps. the legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development process. The historical review determined that some of the risk evaluations conducted in the past did not fully account for all the risks associated with the issues. After re-evaluating the patient risk, Smiths Medical determined that the issues identified were associated with sufficient patient risk that it is necessary to notify users and apply to pump versions before v5.0.0.

Recall start date: November 7, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Smiths Medical Asd, Inc.
6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74634